ITN Announces Enrollment of First Participant in T1DAL Trial for People Recently Diagnosed with Type 1 Diabetes

April 1, 2011 --

The Immune Tolerance Network (ITN) today announced enrollment of the first participant in a phase II clinical research trial evaluating whether intramuscular injections of alefacept (Amevive®) halt or slow the destruction of insulin-producing beta cells in patients recently diagnosed with type 1 diabetes. The research trial, Inducing Remission in New-Onset Type 1 Diabetes with Alefacept (T1DAL), is seeking 66 eligible participants at approximately 15 clinical research centers nationwide.

The T1DAL trial is being conducted by the ITN and is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Additional funding for the study is provided by the Special Statutory Funding Program for Type 1 Diabetes Research, a special appropriation for the research on the prevention and cure of type 1 diabetes. Astellas Pharma US Inc. is providing the Amevive® for the study.

“The T1DAL trial is an important step forward in our attempts to rescue beta cells in type 1 diabetes,” said Gerald Nepom, MD, director of the ITN. “This drug is designed to alter the immune system in ways that may stop disease progression in this very challenging disease.”

At the time of clinical diagnosis of type 1 diabetes, it is believed that a substantial number of beta cells in the pancreas remain and continue to produce a small amount of insulin, which lessens over time. T1DAL is investigating the ability of alefacept (Amevive ®), a protein that reduces the activity of specific immune cells known as T cells, thus protecting the residual beta cells in individuals with new-onset type 1 diabetes from ongoing autoimmune destruction. Although alefacept (Amevive®) has never been tested in patients with diabetes, it has already been approved by the FDA for the use in treating another autoimmune disease called plaque psoriasis and possesses a strong safety profile in that patient population.

Eligible participants will be randomly assigned to receive weekly intramuscular injections of alefacept (Amevive ®) or placebo for two 12-week periods. T1DAL is designed to test if weekly shots of alefacept can halt the destruction of these remaining beta cells in the pancreas and prolong one’s ability to produce insulin.

“This project brings together key basic and clinical discoveries in many fields inside and outside type 1 diabetes research, over many decades,” said Mark Rigby, MD, PhD, the protocol chair for the T1DAL trial and Assistant Professor of Departments of Pediatrics and Surgery at Emory University School of Medicine and Children’s Healthcare of Atlanta. “In T1DAL, we are targeting what we believe to be the most damaging, rogue immune cells in the body that are actively involved in the destruction of beta cells early on in type 1 diabetes. Due to alefacept’s use in the treatment of another immune-based disease and the safety profile established with that illness, we are confident that we will be able to do this with minimal impact on the protective aspects of the immune system. We believe that this is one critical step in the path to finding a cure for this disease.”

T1DAL is currently seeking participants between the ages of 12 to 35 years who have been diagnosed with type 1 diabetes mellitus within 100 days of enrollment in the trial. Enrollment is expected to continue for approximately two years.

University of California, San Francisco Diabetes Center; San Francisco, CA

Barbara Davis Center for Childhood Diabetes at the University of Colorado, Denver; Aurora, CO

Benaroya Research Institute at Virginia Mason; Seattle, WA

University of Maryland Medical Center; Baltimore, MD

Massachusetts General Hospital; Boston, MA

University of Miami School of Medicine; Miami, FL

Children’s Hospital of Philadelphia; Philadelphia, PA

Creighton University; Omaha, NE

University of North Carolina Diabetes Care Center; Durham, NC

Children’s Mercy Hospital; Kansas City, MO

UT Southwestern Medical Center; Dallas, TX

University of Rochester Medical Center; Rochester, NY

University of Arizona; Tucson, AZ

University of Iowa Health Care; Iowa City, IA

The ITN is an international research consortium funded by the National Institute of Allergy and Infectious Diseases and the Juvenile Diabetes Research Foundation International. The ITN develops and conducts clinical studies of immune tolerance therapies—highly targeted treatments designed to prevent disease-causing immune responses, without compromising the natural protective properties of the immune system. The ITN consortium is led by several institutions, including University of California, San Francisco; Benaroya Research Institute at Virginia Mason, Seattle; and Beth Israel Deaconess Medical Center, Boston. For more information about the ITN, visit www.immunetolerance.org